Field of the Invention
This invention is directed to a tamper evident shield assembly for the port of a container such as, but not limited to, an intravenous (IV) bag or container, a medicine vial or another type of container that will typically be, but does not necessarily have to be, related to medicine. The inventive tamper evident shield assembly includes a housing that has a hollow interior as well as movably connected first and second housing segments that are selectively disposed from an open orientation and into a closed orientation. Additionally, a lock assembly is disposed on an exterior of the housing and operates to maintain the first and second housing segments in the closed orientation. The inventive tamper evident shield assembly also includes a frangible structure which, along with other structure, serves to assist with providing an indication as to if and when the inventive shield assembly has been tampered with.
Description of the Related Art
In medical care facilities across this country and in other countries, it is common practice for medical doctors and other authorized medical personnel to order that a patient be given a drug or medication orally, as well as by injection and by intravenous (IV) administration. As just one example of how common this is, it is currently estimated that more than 16 billion injections are administered on a worldwide basis in any given year.
Also, and as the costs of many new and other drugs can be quite expensive, it is becoming relatively common in hospital settings for a number of syringes and other types of medical containers to be pre-loaded or filled by a pharmacist, or other authorized personnel within a hospital or similar facility, at an appropriate location for subsequent dispensing to one or more patients. The pharmacy or other location where syringes and other types of medical containers are filled can and often will be located in a remote part of the hospital, relative to the patient care area where the medicine is to be administered. In some cases, the pre-loading of syringes and other medical containers occurs in another building or facility entirely, often referred to as “third party pharmacies.” This may even be a growing trend among hospitals to limit certain costs. Regardless, pre-loaded syringes and other medical containers can be delivered to a large number of nurse's stations in multiple hospital or medical buildings. Because many nurse's stations are typically remotely located from the pharmacy or other station that pre-loads syringes and the like with drugs, these are quite often given to another person for delivery to a nurse's station, for subsequent dosing of the patient by qualified personnel. From the foregoing, it may be understood that during the course of loading a syringe or other medical container with a drug, and delivering it to a nurse's station or to a patient, numerous personnel can easily be involved with the handling of the device and the drug inside.
Moreover, and especially in the case of a very expensive drug or an addictive drug that has been prescribed for a patient, such as morphine, there is some danger that a pre-loaded syringe or other medical container will be tampered with at some point by a person seeking to improperly gain access to the drug. This possibility can present real danger when an unauthorized person gains access to the contents of a pre-loaded syringe or other medical container. By way of examples only, the sterility of the syringe or medical container and/or its contents can become contaminated, or another possible outcome could involve the inappropriate substitution of some other, unauthorized substance in the syringe or other medical container, such as if saline solution were substituted for a dose of morphine. Thus, there is a problem of determining if a sealed, preloaded syringe or medication container has, or has not, been tampered with or has otherwise been exposed to contamination. These and related types of problems have been described in one or more of the present inventor's own previously granted U.S. patents, such as U.S. Pat. Nos. 8,348,895 and 8,591,462, both of which are incorporated herein by reference, as well as in other parties' patents, such as U.S. Pat. No. 5,328,474 to Raines.
However, certain problems remain in this particular field of art, despite the introduction of inventive products previously, such as those represented in the present inventor's own U.S. patents. For example, one problem relates to the ability to manufacture tamper evident devices in a manner that is both relatively easy and inexpensive, while another problem relates to the manner in which such tamper evident devices are assembled and placed on a syringe that has been pre-loaded with a drug, or on another device carrying a substance used to treat patients, such as an intravenous (IV) bag or medicine vial. Yet additional problems relate to the maintenance of sterility of such pre-loaded syringes and other medical containers during filling and storage at the manufacturing facility and during transport to and throughout the various hospital and medical buildings where they will be used. Accordingly, the present invention seeks to address such problems associated with the handling of tamper evident devices, whether as end caps or other closures that are used with syringes or as yet other containers associated with the storage and/or administering of medicine, and to address such problems regardless of whether they arise at the stage of manufacture, assembly, the loading of a drug or medicine, or further downstream, such as during their transport, storage or administration of same.
Therefore, there is a need for an improved, tamper evident device which is capable of being used with standard or conventional pre-loaded syringes, whether for administration of a drug orally or by injection, and with other medication administering or storing containers, in a manner which overcomes the problems and disadvantages that remain in this field of art, such as those referred to above. If any such improved tamper evident device were developed, it would preferably have appropriate and advantageous structural and operative features, and might include, but not be limited to, having an integral or one piece construction which facilitates a suitable interconnection with or mounting on a preloaded syringe or other container for medicine.
In addition, if any such improved tamper evident device were developed, it would preferably be structured to provide a clear and unmistakable indication of tampering or an attempt to gain access to the contents of the pre-loaded syringe or other container of medicine. Further, the structuring of any such tamper evident device, if one were developed, should be such as to prevent the opening thereof in order to provide access without requiring the complete or partial destruction of the tamper evident device, so that as a result, such structural damage to the device would be clear evidence of an attempted tampering. Finally, if any such improved tamper evident device were developed, it should also be structurally and operatively reliable, while being capable of being quickly and easily mounted in a protective position relative to the port, closure or syringe cap, etc. associated with the medication storage or administering container, in order to facilitate widespread use and acceptance throughout the medical field.